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NCT05836883 · ClinicalTrials.gov registry record · Phase 1

Study of ExoFlo for the Treatment of Perianal Fistulas

A Phase 1 study, sponsored by Direct Biologics.

Terminated
Registry status
Phase 1
Development phase
5
Enrollment target

NCT05836883: Clinical Trial Phase 1 study, sponsored by Direct Biologics.

NCT05836883 is a Phase 1 study that was terminated before completion, run by Direct Biologics. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05836883, a Phase 1 study, was terminated before completion, sponsored by Direct Biologics.

TERMINATED
Registry status
Phase 1
Development phase
5 participants
Enrollment target

Study Summary

To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohn's Disease.

Interventions

  • BIOLOGICAL ExoFlo
  • OTHER Local injection of normal saline

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2023-08-28
Est. Completion 2024-12-01
Phase Phase 1
Direct Biologics

7 total trials

Why NCT05836883 stopped before completion

NCT05836883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which ExoFlo is the first listed.

NCT05836883 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05836883 about?

NCT05836883 is a clinical study titled "Study of ExoFlo for the Treatment of Perianal Fistulas". To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohn's Disease.

What is the current status of trial NCT05836883?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2023-08-28. Estimated completion is 2024-12-01.

What interventions are being tested in trial NCT05836883?

The interventions under investigation include: ExoFlo (BIOLOGICAL), Local injection of normal saline (OTHER).

Who is sponsoring clinical trial NCT05836883?

This trial is sponsored by Direct Biologics, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05836883's enrollment target sits among peer trials

5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05836883, the US trial registry maintained by the National Library of Medicine. NCT05836883 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.